MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS by MEDTRADE PRODUCTS LTD.

MedTrade Product's Antiseptic Barrier Hydrogel Dressings consist of an Antiseptic Hydrogel, which is over 70% pure water. Effective antiseptic barrier protection of the dressing against microbes and microbial contamination is provided by the antiseptic barrier hydrogel and adhesive film cover of the dressing is made from a special Antiseptic Barrier hydrogel formulation which not only has a high water activity (a measure of cooling) but is also capable of absorbing substantial quantities of fluid. This makes it especially suitable for use on burns with minimal risk of maceration. The Antiseptic Barrier hydrogel dressings are highly conformable, soft, absorbent, sterile, primary wound dressings of a gelatinous mass which provides a moist healing environment.

AI/ML Overview

The provided 510(k) summary for MedTrade Product's Antiseptic Barrier Hydrogel Dressings does not contain information typically found in acceptance criteria or a detailed study report for device performance in the context of diagnostic or AI-enabled medical devices. This document is for a medical device (a dressing) and focuses on its substantial equivalence to a predicate device and its physical and chemical properties and general safety, rather than statistical performance metrics like sensitivity, specificity, accuracy, or reader improvement.

Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory submission. The information that can be inferred or directly stated is provided below.

Acceptance Criteria and Study for MedTrade Product's Antiseptic Barrier Hydrogel Dressings

This 510(k) submission primarily demonstrates substantial equivalence to a predicate device (MedTrade Product's Hydrogel Island Dressings K002504) and outlines the product's physical characteristics, intended use, and general safety testing. It does not include performance data or acceptance criteria related to diagnostic accuracy, reader performance improvement, or AI algorithm standalone performance, as these are not relevant for this type of medical dressing.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic / Test	Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate	Device is substantially equivalent in design, composition, and function to MedTrade Product's Hydrogel Island Dressings K002504, with the addition of an antiseptic to provide an antiseptic barrier hydrogel.	The FDA determined the device is substantially equivalent to legally marketed predicate devices.
Antiseptic Barrier Activity	(Implicit) Demonstrate "Antiseptic Barrier activity".	"MedTrade Products Antiseptic Barrier Hydrogel has been shown to have 'Antiseptic Barrier activity'." (No specific metric or threshold provided in this document).
Sterilization	Meet requirements of ANS/AAMI/ISO11137 - 1995 and AAMI TIR8-1991 for Method 1 dosimetric release with a sterility assurance level of 10⁻⁶.	Product is gamma irradiated in accordance with the specified standards for qualification for Method 1 for dosimetric release with a sterility assurance level of 10⁻⁶. Supplied sterile.
Biocompatibility (Dermal Irritation)	(Implicit) Successful completion per ISO/Tripartite guidelines.	Biocompatibility testing including Dermal Irritation has been successfully completed per ISO/Tripartite guidelines.
Biocompatibility (Dermal Sensitization)	(Implicit) Successful completion per ISO/Tripartite guidelines.	Biocompatibility testing including Dermal Sensitization has been successfully completed per ISO/Tripartite guidelines.
Biocompatibility (Cytotoxicity)	(Implicit) Successful completion per ISO/Tripartite guidelines.	Biocompatibility testing including Cytotoxicity has been successfully completed per ISO/Tripartite guidelines.
Biocompatibility (Acute Systemic Toxicity)	(Implicit) Successful completion per ISO/Tripartite guidelines.	Biocompatibility testing including Acute Systemic Toxicity has been successfully completed per ISO/Tripartite guidelines.
Biocompatibility (Hemocompatibility/Hemolysis)	(Implicit) Successful completion per ISO/Tripartite guidelines.	Biocompatibility testing including Hemocompatibility/Hemolysis has been successfully completed per ISO/Tripartite guidelines.
Indicated Uses (OTC)	Safe and effective for OTC use on minor cuts & grazes, minor scalds & burns, and insect bites.	Indicated for OTC use on minor cuts & grazes, minor scalds & burns, and insect bites. (FDA's substantial equivalence determination implies acceptance of this indication).
Contraindications	Clearly define any contraindications.	Contraindicated for: Third degree burns.
Composition (Hydrogel)	High water content medical grade hydrophilic polymer.	High water content medical grade hydrophilic polymer. (Matches predicate).
Composition (Backing)	Self Adhesive Film.	Self Adhesive Film. (Matches predicate).
Composition (Adhesive)	Medical grade pressure sensitive adhesive.	Medical grade pressure sensitive adhesive. (Matches predicate).
Composition (Adhesive Coverage)	100% on backing.	100% on backing. (Matches predicate).
Packaging	Printed Pouch.	Printed Pouch. (Matches predicate).

2. Sample size used for the test set and the data provenance:

This document does not specify a "test set" in the context of evaluating diagnostic performance.
Biocompatibility testing would have involved specific animal and/or in-vitro samples, but the sample sizes and detailed data provenance (e.g., country of origin, retrospective/prospective) are not disclosed in this summary.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

Not applicable as this is not a diagnostic device involving expert interpretation of data. Ground truth, in this context, would relate to the successful completion of specific standardized tests (e.g., sterility, biocompatibility), which are typically pass/fail criteria against established scientific guidelines, not expert consensus.

4. Adjudication method for the test set:

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable as this is not an AI-enabled diagnostic device or software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable as this is not an algorithm or AI device.

7. The type of ground truth used:

For sterility: Laboratory testing against a Sterility Assurance Level (SAL) of 10⁻⁶ per specified ISO/AAMI standards.
For biocompatibility: Successful completion of tests (Dermal Irritation, Dermal Sensitization, Cytotoxicity, Acute Systemic Toxicity, Hemocompatibility/Hemolysis) based on ISO/Tripartite guidelines.
For antiseptic barrier activity: "Shown to have 'Antiseptic Barrier activity'" - the specific method or ground truth definition is not provided in this summary but would typically involve standardized microbiological challenge tests.

8. The sample size for the training set:

Not applicable as this is not an AI-enabled device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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AUG 2 2 2003

510k Summary
K022587

H. Safety & Effectiveness: MedTrade Product's Antiseptic Barrier Hydrogel Dressings Classification Name: NAE 878.4022 Bandage Liquid

Contact: Jonathan Ranfield, Director of Quality Assurance & Regulatory Affairs

MedTrade Products Ltd, Electra House, Crewe Business Park, Crewe, CW1 6GL. UK. Tel: +44 (0) 1270 500019. Fax: +44 (0) 1270 500045

Prepared: August 10, 2002

Description: MedTrade Product's Antiseptic Barrier Hydrogel Dressings consist of an Antiseptic Hydrogel, which is over 70% pure water. Effective antiseptic barrier protection of the dressing against microbes and microbial contamination is provided by the antiseptic barrier hydrogel and adhesive film cover of the dressing is made from a special Antiseptic Barrier hydrogel formulation which not only has a high water activity (a measure of cooling) but is also capable of absorbing substantial quantities of fluid. This makes it especially suitable for use on burns with minimal risk of maceration. The Antiseptic Barrier hydrogel dressings are highly conformable, soft, absorbent, sterile, primary wound dressings of a gelatinous mass which provides a moist healing environment.

MedTrade Product's Antiseptic Barrier Hydrogel Dressings are indicated for OTC use on minor cuts & grazes, minor scalds & burns and insect bites. If at any time you are unsure of the above conditions or type of wound consult a health care professional.

Dressings are supplied sterile in single use pouches. Product is gamma irradiated in accordance with the Sterilisation of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilisation, 300 Edition (ANS/AAMI/ISO11137 - 1995) and Microbiological Methods for Gamma Sterilisation (AAMI TIR8-1991) for qualification for Method 1 for dosimetric release with a sterility assurance level of 10 -Biocompatability testing including: Dermal Irritation, Dermal Sensitization, Cytotoxicity, Acute Systemic Toxicity and Hemocompatibility/Hemolysis have been successfully completed per ISO/Tripartite guidelines.

MedTrade Product's Antiseptic Barrier Hydrogel Dressings are substantially equivalent in design, composition and function to MedTrade Product's Hydrogel Island Dressings K002504, with the addition of an antiseptic, to provide an antiseptic barrier hydrogel. A table of comparative features may be found below.

Characteristics	MedTrade Product'sHydrogel Island DressingExempted 510(k) K002504	MedTrade Product'sAntiseptic Barrier HydrogelIsland Dressing
Hydrogel - Composition	High water content medicalgrade hydrophilic polymer	High water content medicalgrade hydrophilic polymer
Backing	Self Adhesive Film	Self Adhesive Film
Adhesive	Medical grade pressuresensitive adhesive	Medical grade pressure sensitiveadhesive
Adhesive Coverage	100% on backing	100% on backing
Indications For Use	Minor cuts & grazesMinor scalds & burnsInsect Bites	Minor cuts & grazesMinor scalds & burnsInsect Bites
Packaging	Printed Pouch	Printed Pouch
Supplied	Sterile	Sterile

ATIVE

Additionally, MedTrade Products Antiseptic Barrier Hydrogel has been shown to have "Antiseptic Barrier activity".

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AUG 22 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jonathan Ranfield Director, Quality Assurance & Regulatory Affairs MedTrade Products Ltd. Electra House Crewe Business Park Crewe, Cheshire United Kingdom CW1 6GL

Re: K022587

Trade/Device Name: MedTrade Product's Antiseptic Barrier Hydrogel Dressings Regulatory Class: Unclassified Product Code: MGQ Dated: June 18, 2003 Received: June 20, 2003

Dear Mr. Ranfield:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Jonathan Ranfield

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Wilkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known) . KO22587 ............................................................................................

Device Name: MedTrade Product's Antiseptic Barrier Hydrogel Dressings

These dressings are intended for OTC use on wounds such as:

Minor cuts and grazes .
Minor scalds and burns .
Insect bites .

MedTrade Products Antiseptic Barrier Hydrogel Dressings are contraindicated for:

. Third degree burns
The components do not contain animal ingredients.

(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.190)	Or	Over The Counter Use	X	(Optional Format 1-2-96)
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(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

510(k) Number	K022587
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Regulation Number and Section

N/A